Laboratories that analyze the function and/or the phenotype of white blood cells (lymphocytes/leukocytes) comprising the immune system are surveyed and permitted through the Clinical Laboratory Evaluation Program (CLEP). 

Category descriptions [2] are provided. 

Laboratories are required to demonstrate compliance with:

• Part 1 General Systems Standard (effective January 1, 2017) [3]
• Cellular Immunology and Cytokines (effective June 1, 2017) [4]

Cellular Immunology – Non-Malignant Leukocyte Immunophenotyping Sustaining Standard of Practice 16 (CINM S16): Lymphocyte enumeration- Multi-color CD Subset Definitions was deleted on June 1, 2017.

For method approval [5] and validations, please return the completed Cellular Immunology Checklist [6] to the address indicated on the form.